MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 STAR DRIVER 20 SU; SHOULDER INSTRUMENT - SCREWDRIVER

Catalog Number	750510103
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tine of the t20 screwdriver broke off while tightening peripheral screw.The piece was morse tapered into screw, was not removed.
Additional Manufacturer Narrative
Product complaint #(b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received states that there was a delay of 2 minutes to retrieve another screwdriver and no reported adverse effects.There was a piece of the screwdriver top lodged in the screw.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative: added: b5, g1 (manufacturing site name).

• Brand Name: STAR DRIVER 20 SU
• Common Device Name: SHOULDER INSTRUMENT - SCREWDRIVER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20911869
• Report Number: 1818910-2024-25245
• Device Sequence Number: 12878172
• Product Code: HWR
• UDI-Device Identifier: 10603295552611
• UDI-Public: (01)10603295552611(10)217834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 750510103
• Device Lot Number: 217834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female